Catherine Scart-Gres

WORK HISTORY

ABOUT CATHERINE SCART-GRES

Over 30 years in the pharmaceutical industry in Clinical Development and Medical Affairs for local and global business, and across all phases of the product life cycle. Pre-clinical (NCO, CMC) and Clinical Development (from phase I to phase IV) expertise, including knowledge of relevant international regulations and guidelines. Experience in Clinical Research, including designing, planning and execution of local or international clinical trials. Familiarity with basics of biostatistics and data analysis. Experience with Regulatory Authorities and knowledge of US and EU regulatory requirements (Scientific Advice, ODD, PIP, PSP, pre-IND, IND, CTA, MA or NDA…) Scientific and medical expertise in specific therapeutic areas (neurology, psychiatry, cardiology, metabolic, anesthesia, immunology, urology, pediatry.) and Key Opinion Leaders management. Market access (early access programs, pricing and reimbursement process) and post marketing experience (medical affairs, pharmaco-vigilance, and Med educational programs, Exhibits and Symposia organization, Professional Relations)- Expérience de la pratique quotidienne en médecine de ville (durant 7 ans), suivie d\'une expérience de plus de 20 ans dans l\'industrie pharmaceutique en Recherche Clinique et aux Affaires Médicales: conduite des essais cliniques (phase I à IV) et études observationnelles (de la conception à l\'exploitation), BPC, gestion des KOL, medico-marketing, market access, Pharmaco-épidémiologie, pharmaco-vigilance (Responsable PV et EQP) et formation des ventes. Recherche et développement clinique de la phase I à IV avec une expertise principalement dans les domaines du SNC(neurologie et psychiatrie & addictions), risques CV (Stroke, HTA, diabète, dyslipidémies), immunologie, hémostase, critical care ( choc septique, angio-oedeme héréditaire.)